Wednesday, March 28, 2012

Partnerships in Clinical Trials Latin America 2012 Program is Now Available

The World’s leading clinical trials event, Partnerships in Clinical Trials returns to Latin America for the third time, bringing more global leaders to share perspectives on the latest global trends and clinical outsourcing and development strategies. This event enables you to partner to drive innovation through a brand new Innovation Consortium for Regional R&D and Clinical Leadership, and meet face-to-face with current and future partners through more structured networking opportunities than any other event in the region. View highlights from previous events.

Partnerships in Clinical Trials Latin America will take place August 13-15, 2012, in Sao Paulo, Brazil.  Download the agenda here.

Features of the PCTLA Program:
GLOBAL TREND SPOTLIGHTS!

  • → Perspectives on Global Sourcing and Spending of Clinical Trial Investments Around the World- a comprehensive overview of the evolving clinical trial outsourcing landscape with an eye toward financial considerations, including the impact of M&A on clinical trials in LATAM, Wall Street’s Perspective, and case studies to help guide your strategic decision making.John Kregar, Principal, Healthcare Equity Research Analyst, William Blair & Company
  • → Creating Transformational Change: How to Retool R&D to Produce More, Better, and Affordable Innovation-a close look at how R&D models are changing and how the industry could translate innovation research into better business models through strategic partnerships and collaborative initiatives that will result in increased output of new medicines.  Bernard Munos, Chief Apostle, Breakthrough Innovation, Innothink Center for Research in Biomedical Innovation
  • → Tapping into the Promise of Regenerative Medicine in Latin America- a comprehensive look at the current happenings in the field of regenerative medicine especially in the areas of cell therapies and tissue engineering with a focus on future opportunities for the Latin America region.  Abner Mhashilkar, PhD, Medical Translation Officer, WFIRM, Wake Forest School of Medicine


LESSONS LEARNED FROM REAL-WORLD EXPERIENCES ON QUALITY MANAGEMENT
→ Keynote: Avoid Unwanted Surprises in Outsourcing: Lessons Learned on How to Build Effective Partnerships with CROs in Latin America
Jeffrey S. Kasher, PhD, Vice President and Chief Operating Officer, Global Clinical Development, Eli Lilly
→ Best Practices for Proactive Quality Management
Patricia Leucthen, CEO, The Avoca Group
→ Monitoring for Quality: Implement Risk-Based Clinical Monitoring in Latin America
Jon Lee, Vice President, Development Operations, Cerexa

LATIN AMERICA R&D INNOVATION CONSORTIUM
An interactive forum focused on bringing together regional R&D leadership to create solutions to shared challenges. This moderated discussion will enable you to:






Wednesday, March 21, 2012

Clinical Trial Begins in Africa for TB Treatment

South Africa, Tanzania and Brazil are the sites for a Phase II tuberculosis trial. This new novel drug combination strives to take care of TB where other drugs can't - as many strains of TB are now growing immune to the current treatment.  As opposed to the months of treatment with the current medication, this new dosage in Phase II would cut down treatment to six months.  The current tremendous on the market could include injections and often takes compliance for up to 18 months to work.  With 9 million contracting this disease a year, it's critical to find a treatment that can extinguish both TB and MDR-TB, which is not reacting to any of the current treatment options.

Mel Spigelman, MD, President and CEO, the TB Alliance told African Science News, “There is new momentum and new hope in TB research – as shown by this and several other novel regimen trials that will soon be launched. This novel TB drug regimen has the potential to unlock a new and more efficient approach to tackling TB. In essence, it’s a step toward erasing the distinction between TB and MDR-TB—and in the process, dramatically shortening, simplifying, and improving treatment.”




Monday, March 12, 2012

Call for Speakers: 4th Annual Partnerships in Clinical Trials Asia

The Institute for International Research is looking for suggested sessions for our upcoming 4th Annual Partnerships in Clinical Trials Asia event, to be held September 12-14, 2012 at the Grand Hyatt Hotel in Shanghai, China.

This is the premier event for global and regional clinical leaders to build effective partnerships and implement innovative strategies to ensure clinical development success in Asia.

We invite you to submit a proposal for a speaking opportunity directly to Danya Burakoff, by March 20th, 2012. Please send to me at dburakoff@iirusa.com.

We are currently recruiting pharmaceutical and biotech executives, principal investigators, and industry insiders who can share NEW DATA through detailed case studies related to Clinical trials in Asia.
Submission Guidelines & Details In your abstract, please provide the following:
  • • Proposed Title of Session: Objective and purpose
  • • A descriptive paragraph of 3-4 sentences describing what is unique or special about the information you plan to share- aka Background Information
  • • 3-4 bullet points highlighting the strategies, tools and techniques attendees will walk away with- aka Key Takeaways
For more information on the 4th Annual Partnerships in Clinical Trials Asia Event, visit the webpage.
We look forward to welcoming you to the event this fall!

-Danya Burakoff, Program Director, Partnerships in Clinical Trials Asia




Friday, March 9, 2012

#PCTUS 2012: Comparative effectiveness and untapped markets

You Ask, They Answer: How Comparative effectiveness research May Impact Drug Pipelines, Innovation and Patient Care— Can Innovation Survive CER?
Moderator: John Lewis, Vice President of Public Affairs, ASSOCIATION OF CLINICAL RESEARCH ORGANIZATIONS
Felix Frueh, PhD, President, Medco
Research Institute, MEDCO HEALTH SOLUTIONS, INC.
Angela Olstrom, Director Federal Relations, EPILEPSY FOUNDATION
John Doyle, Senior Vice President, QUINTILES CONSULTING


Doyle's job focuses on health economics and outcomes research. He wants the healthcare system to post perform in the US. CE research is a new domain of evidence that Pharma companies should and can develop. What are the payers (Medco), patient sand physician groups asking for in regards to evidence of value. Disconnect in terms of efficacy to the regulator to what can be seen in the real world. Can we now validate the trial findings in the real world? Angela believes that patient centered research shows effectiveness – for the patient it should be more than just the clinical outcome but also to contribute to a better life. Patients and advocates care about cost, but a medication that leads to more freedom in life will the worth more money. Frueh believes it’s important not to miss the point that when looking at cost and medication and who it’s better for, you have to look at both parties. The pill that works for 60% of the population versus the drug that works for 30% of the population isn’t necessarily any different in value.

Capture and Navigate New Markets—Reset your Compass for Business Transformation by Profitably Tackling the Challenge of Entering New Markets, Wherever They Are
Steve Wunker, Author, CAPTURING NEW MARKETS

Image Source
What are the principles for success for companies in transition? The strategy that you have can be a blinder. Business models ossify, to a business model to suit new technology can be difficult to accomplish. Value is often unstated, possibility is not in what has been developed but additional tools that come with the new product. You can ignore the future, but it will come back to prove irrelevance for your company. A great example is Kodak and the digital camera. What makes a company great initially often makes it a downfall in the future. IF a company is complicated, centralized and costly, it's constrained. Wunker draws a parallel to the Pharma industry now to the Kodak/Picture industry in the late 1800s. Wunker points out Walgreens as a company who has successfully overcome stiff competition from their competitors. They made the Pharmacy indispensable by bringing doctors into the facilities, letting pharmacists council patient son their medications, successfully overcoming the challenges brought on by competitors. (Beacons for business model innovation). In a study, 5,0000 innovation had an average return of 4.5%. But 2% of the created over 90% of their cumulative value.

What are some of the things to consider when looking at new markets and clinical trial development: real-world populations (those who are sick, far away), real-world circumstances (adherence), leveraging EMR data in new ways (understand who the population that responds and who doesn't)

Essential clear strategy, reflect strategy in the organizational structure and generate data that shows impact and allows others to replicate programs.

Wunker suggests starting with what company needs in the end, then build from the top down.  He concluded his speech with seven tips to help find markets that are yet to be discovered:

  1. 1) Beware old strategies, business models and value
  2. 2) Break through consumption constraints
  3. 3) Integrate technologies, business models and partnerships
  4. 4) Leverage hidden jewels
  5. 5) Re-frame markets with jobs
  6. 6) Innovate the business model and experience
  7. 7) Focus your efforts through a very clear strategy




Wednesday, March 7, 2012

#PCTUS 2012: Innovation in Clinical Trials

Day 2 of Partnerships in Clinical Trials kicked off with a focus on innovation and how the Pharma industry can look to the future with success.

Changing Your Game—How Clinical executives Can Succeed by Increasing Global Competitiveness and Driving revenue with Innovation
Ram Charan, THE GAME-CHANGER: HOW YOU CAN DRIVE REVENUE AND PROFIT GROWTH WITH INNOVATION 

Innovate or die. If you don’t grow, you will die and lack of innovation will contribute. Everyone in an organization needs to be a part of an innovation team. It builds organizational muscles and opens the mind. Make change friendly, it’s a good thing for innovators. Innovation is beyond the prototype – reach out and find new markets. Invention and innovation are two different things. Invention is creating an idea. Innovation is converting an idea into life.

What are a few things to help you evaluate the value of an innovative idea? Will it lead to more revenue, give you a competitive advantage, bring you into a new game, and does it give your customers a better brand appreciation? Innovation is the social process from the time you select an idea to the delivery. If you can figure out the “secret sauce”, you can then institutionalize that idea. What are the tools that are used and can be modified so that they can be institutionalized? In innovation, focusing is critical.

Capacity of the organization to handle more than four products well is nearly impossible. Charan encourages companies to focuses on a few core competences, and observe the differentiation when they’re successful. Integrators to build these things in your company, often diverse disciplines, are able to integrate new ideas into companies.

Focus and integration are two pivotal steps to bring innovation to the. Building trust in human beings come from frequency of practice. Each of us is responsible for our own grown, and innovation is the key to this. If individuals learn by doing, you’ll build a string of innovations.

The government is driving the game change in the financial industry. Look at the phenomenon from a different angle.

Industry Sit Down: Aligning to Innovate—Sponsors & CROs Partnering to Significantly Improve Success Rates for Clinical Trials
Moderator: Ram Charan, Author, GAME CHANGER
Rene Sluijter, Global head Outsourcing, ABBOTT LABORATORIRS
Daniel Perlman, Chairman and CEO, RPS
William Sharbaugh, Chief Operating Officer, PPD, Inc.
Meryl Wiernik , Senior Director Strategic Outsourcing, TEVA 

There are no techniques to properly integrate a CRO in to the Sponsor. This is the place the integrator comes in. Once they’re integrated and incorporated, nothing can replace their success. Bill Sharbaugh at PPD is a big Pharma guy but moved to CROs. There are two solutions to confront the problem of innovation: Scientific innovation and business model innovation. The lines of innovation, both scientific and business, are now being blurred as opposed to CROs and business innovation and Pharma with scientific innovation.

We need to open our minds to find the new ideas. Meryl Wiernik of Teva points out that growth through acquisition is how TEVA has grown over the past few years. As a company, they want to globally standardize. It is about building communications and relations through suppliers and innovation together. The power of simultaneous dialogues throughout different stakeholders in the organization is key.

Why is it taking so long for Pharma/Life Sciences that many countries in other industries learned 20 years ago. Dan Perlman of RPS believes the number one problem is too much money. Pharma would give money to any project, but other industries have always been financially controlled. Also, the outsourced vendors, who are coming from an overflow, therefore there was no forced innovation. It was all heading towards a patent cliff, creating panic. This will lead to better models and efficiency. Sharbaugh believes Pharma has realized they need the right kind of leadership and Pharma, and they’re experimenting to do this. GMs are moving into scientific organizations to solve this problem. Scientific professionals should be moving into learn a little about commercial leadership.

Most companies that are integrating don’t spend enough time discussing and identifying cultural differences and how to merge them. Individual companies have capacity for innovation depending on their culture. Leadership drives innovation. The best partnerships come through cultural alignment. Seek advice from others who have outsourced. Be laser focused on what separates you from everyone else. Bring data driven examples of where you can excel to stand out in the eyes of Pharma. With an RFP, sponsors and CROs should do the research. The vendor’s structures should show how they meet the cost and the deliverables.

Point, Counterpoint: The R&D Path Going Forward: How do we Re-Invigorate Drug Research?
Bernard Munos, Founder, INNOTHINK CENTER FOR RESEARCH IN BIOMEDICAL INNOVATION
John Lamatina, Former President of R&D, PFIZER INC
Kenneth Somberg, Chief Medical Officer, Covance 

The clinical trial industry is facing extinction and fast because of the money. The money is being wasted. If this industry can’t conduct clinical trials, it will soon be extinct. The system is broken – including sponsors and CROS, but much broader including legislators and society. The fact that drugs are approved the way they are is questionable – after a trial one size fits all.

Is the industry doing enough to change the system? There’s quite a bit of inertia in the system. Change happens only under duress. That’s not enough. A different vision has to be articulated. Some companies have that leadership, but many are not. No matter how many biomarkers, long-term monitoring is needed. Companies with limited budgets should take shots at the big players. Sablinski believes clinical trials cost too much per patient. In order for CROs to thrive, they need to figure out the best way they can do that. A lot of money is spent identifying patient – but with an electronic system, this could change. If we accept that clinical research is unaffordable, someone’s revenue line is going get hit, and no one wants that is to happen. The cost pressures being put upon the industry in Europe will eventually travel to the US as well. The industry needs to soul search and reconcile the fact that innovation is disruptive and maybe the Pharma industry needs to destruct itself.

How realistic it t for drug development to change in light of the FDA? The FDA is a great excuse for intellectual laziness. The FDA is a great excuse for intellectual laziness. It’s easier to sit and say “I can’t do it” with someone to lay the blame on. One panelist believes they are encouraging innovation. Today’s FDA is willing to embrace change.




#PCT 2012: Congratulations to all of our awards winners!

The 2nd Annual Partnerships in Clinical Trials Awards took place last night where we honored some of the valued members of the clinical trials community.  Congratulations to all of our winners!

Biopharmaceutical Leadership: Deidre BeVard, Vice President, Development Operations, Endo Pharmaceuticals
Clinical Trial Innovation: Craig Lipset, Head of Clinical Innovation, Pfizer, Inc.
Novel Application of Technology for Clinical Trials: Peter S. Benton, Executive Vice President, eClinical Solutions, Bioclinica, Inc.
Clinical Trial Business Women of the Year: Gena Reed, CEO, Paragon Biomedical
Special Recognition: Jae Chung, Founder & CEO, goBalto & Covance, Inc.
Clinical Trial Business Women of the Year: Gena Reed, CEO, Paragon Biomedical




#PCTUS 2012: Collective intelligence and the capital to support it

Crowdsourcing Clinical Development and Medical Innovation
James Surowiecki, Columnist for THE NEW YORKER, Author, THE WISDOM OF CROWDS

Under the rights conditions, groups of people can be extremely intelligent. For drugs, if you can figure out how to collect into the collective knowledge of partners, employees and patients, your ability to make decisions and solve problem and forecast the future. This wisdom of crowds is most important and very visible is the Internet. It is a way to aggregate pieces of knowledge in a quick and affordable way. Google has capitalized on this by treating each link click as a vote, and bringing them to the top of the search.

Four key themes to crowdsourcing:
  1. 1. Some way to aggregate lots of pieces of knowledge to a whole. Use tools to aggregate that kind of knowledge.
  2. 2. The crowd needs to be diverse.
  3. 3. Cognitive diversity is fundamental to problem-solving. Different views to problems have more tools to solve specific problems. In any group, individuals will make mistakes. If their errors are not correlated, the mistakes they make cancel themselves out, leaving the information the group has. It is also a great way to create innovation. Organizations are less comfortable with disagreement than they should be, but the best group decisions don’t emerge out of quick agreement.
  4. 4. You want people to be able to think for themselves, independently. Imitation, however, usually happens. For any individual, it makes sense to follow what everyone is doing. If most people are acting in this way, you may not get the best answer. Recruit the insights of the people who wouldn’t normally ask in the first place.

Groups are smartest when more people are acting as individually as possible.

Industry Sit Down: Disrupting the Traditional Drug Development Process—How will Participatory Medicine Drive Innovation in Clinical Research?
Industry Interviewers:
Gareth Morgan, Head Global Portfolio Management, SHIONOGI INC.
Deirdre BeVard, Vice President, Development Operations, ENDO PHARMACEUTICALS
James Surowiecki, Author, THE WISDOM OF CROWDS
Seth Ginsburg, President, GLOBAL HEALTH LIVING FOUNDATION
Tomasz Sablinski, Founder, TRANSPARENCY LIFE SCIENCES
Craig Lipset, Head of Clinical Innovation, PFIZER INC.

Lipset: Now is the time for community collaboration. At Pfizer, they don’t call it a virtual trial, it’s a participatory trial. Open innovation is captured in their research today. They’re still learning where they can take advantage of those crowds.

Ginsburg: They’re the largest arthritis foundation in the world without arthritis in the name. They want to help shape the conversations that the patients can help with the doctors. They give them the education to ask the doctors the right questions.

Sablinski: Why is the industry doing so many trials no one cares about? The reason is because the design of the trials are contrary to diverse thinking and it’s not decentralized.

There’s a premium for the thing that looks reasonable. Why? Any endeavor is riddled with problems, if you’re doing things that are similar to others, you hit a stumbling block. People in organizations need to do a better job of encouraging people to fail. Ginsberg encourages everybody to look up when they’re walking around, their families, and realize the importance of what the clinical trials community is doing. Live changes fast and be aware of the fact that there are organizations who invest daily in the companies who look into creating the cure for the illnesses that have this affect. Pharma should be aware of the patient communities and advocacy groups, co-creation for these types of things can lead to great results due to the collective intelligence of the participants and those working on the studies.

What are the risks in trials where patients doing the study and sharing? Patients trust other patients. They’re also out there talking online anyway. Lipset thinks we need to think the subjective eligibility criteria. The potential for sharing around the safety needs to be quantified and incorporated into the findings. The energy and technology are being used by patients. You can’t control the crowds, but what you can do is curate their conversations. Curating this content is very difficult but the crowd will support this.

You Ask, They Answer: Virtual Pharma: Show Me the Money!
Moderator: Allan Cohen, Esq., CPA, Director of Legal Services, CELTIC THERAPEUTICS
Kenneth G. Olovich, R.Ph, MBA, Chief Procurement and Financial Officer, CHORUS
Neil McAllister, Chief Business Officer for INC Research and President, AVOS CONSULTING

Olovich believes virtual Pharma gives the ability to tap into research universities around the world as well as future potential buyers. McAlliser believes there are many situations where large companies doesn’t have the resources to really manage the studies. The strategy comes from the drug company, the operation comes from the CRO. There is a greater willingness where they do not have the ability to execute the operational responsibility for CROs. The venture capital climate is changing because of the lack of funding because they don’t want to build infrastructure. VCs are looking at the slowdown and trying to make it virtual so they can still be able to take that to market. This goes for public, large pharma and academia. As a CRO, advisory and executional abilities need to there on the global level.

Wall Street and Private Equity Perspectives—Economic Outlook on Investment Areas, Growth Opportunities, and the Outsourcing Industry

Moderator: Ian Lauf, MBA, Global Sourcing Manager, Medical & Clinical Trial Central Services, BOEHRINGER INGELHEIM PHARMACEUTICALS
Jonathan Leff, Managing Director, WARBURG PINCUS
Eric Coldwell, Managing Director, ROBERT W. BAIRD & CO.
Michael A. Martorelli, CFA, Director, FAIRMOUNT PARTNERS
David Windley, CFA, CPA Managing Director - Healthcare Equity Research, JEFFERIES & COMPANY, INC.
Jeffery McMullen, President and CEO, PHARMANET/i3 

Pharma is experimenting with different models over the past year. What’s been happening? In 2011, we had higher cancellation rates also a very slow revenue growth. Bookings came back in 2009, but this didn’t change things. The one constant thing is that revenue for Pharma public and private is that revenue has not been growing. Outsourcing penetration is going up. It will continue to decrease on the inside. Revenue growth for the CRO industry will be double digits in 2012.

There is an investment in IT technology, ex – Covance announcement at the end of the year. The hope for IT payoff is that it will be in the future. The CRO industry is attractive to the private investors because it has potential for growth and it is very stable. It is also a stable, constant industry.

Do private CROs increase the interest for VCs?  It's important to look at the goal, which is to make money.  A driving philosophy is the idea that by creating new industry leaders enhance the value proposition. It’ s moving to strategic assets and global capability.

Pharmanet’s three focuses in changing: Focus on business continuity. Focus on harmonization. Optimization, an effort to become best in class in everything they do. Will consolidation spill over into Central Labs, ECGs, etc? It’s not believed that bigger deals will increase, they’ll slow down. It will have hard to consolidate applied and e-technology vendors. The buyers of the services want simplification, to get all of their services from fewer vendors.




Tuesday, March 6, 2012

#PCT 2012: How can understanding genomes and sponsor/CRO relationships make for a better industry?

Disruptive Drug Development: Driving the Necessary Innovation and Change to Pioneer the Next Frontier
J. Craig Venter, Founder, Chairman, and President, J. CRAIG VENTER INSTITUTE; Founder and CEO, SYNTHETIC GENOMICS INC

Technology is changing rapidly, last year celebrating the 10th Anniversary of the human genome. Technology has changed; it’s getting simpler, faster and cheaper. Sequencing clinically will change significantly. These machines generate so much data; it’s faster and cheaper to send data via FedEx rather than over optical wires. There is much more genetic diversity within Africa than Africa versus other parts of the world. We have 22-23 million genes. How do all these affect human health?

Stem cells can be a means to studying diagnostic features. Where do mutations develop and why do they develop? Can we understand changes and prevent them, if not, can we repair them. Can we make genetic corrections based on isolated cell lines?

We can now write the genetic code. The implications for science and medicine are now able to be observed.

Industry Sit Down: Seismic Shifts in Clinical Development—The Move Towards Tailored Therapeutics and Personalized Medicine
Moderator: Bernard Munos, Chief Apostle, Breakthrough Innovation, INNOTHINK CENTER FOR RESEARCH IN BIOMEDICAL INNOVATION
Peter Mueller, PhD, CSO & Executive Vice President, Global Research & Development, VERTEX PHARMACEUTICALS
Felix Frueh, PhD, President, Medco Research Institute, MEDCO HEALTH SOLUTIONS, INC.
J. Craig Venter, Founder, Chairman, and President, J. CRAIG VENTER INSTITUTE; Founder and CEO, SYNTHETIC GENOMICS INC.

Venter: There’s a big gap of time between the science breakthrough and it’s permeation into the clinical market. With genetics in clinical trials, it’s not likely to happen anytime soon.

Mueller: We have the beginning of the new field beyond genomes. It’s the translation of the genome into the phenotypically situation. He points to cystic fibrosis as an example with 1800 mutations. You know the information, but it’s hard to start immediately. What does the genomic information in this setting? In cystic fibrosis, it’s beyond the lungs; it affects the whole body system.

Ventor: How can you address these inefficiencies? There’s no substitute to understand the mechanisms of the diseases themselves. When starting to sequence the genome, the effort to find the gene was a 1-2 decade process. At that process, it would have taken 2-3 centuries to use this information. But data process has now changed and it’s quicker. The whole basis of research has changed. Most diseases have multiple genetic outputs. Understanding the fundamentals and complexity from understanding the whole genotype will lead to truly solving the problem. A disease is not a one drug approach. It’s important to bring everyone together to understand the impact of all systems. Research must be done in a different way & bring clinicians in up front to identify not just one biomarker but a set of biomarkers. If it’s done right, the research is translated from the lab into the clinic.

Frueh: The question is once you have this information, how can you get information for payers to understand the evidence. There is a dynamic in the payer community. The ones that say “No” to development are the ones that have formulary decisions and a finite budget over time. They’re working with the payers to find where the opportunities are over time, and looking for alternative options. How much can we pay for drugs that cost $10,000+ a year? So we should look at how much we can pay as a society before it breaks down.

Strategies to Overcome Internal resistance to Change: Tools to Beat Organizational Challenges when Moving to New Outsourcing Models
Frances Grote, Senior Director, Clinical Outsourcing, MILLENNIUM
Kimberly Glen, Vice President, Strategic Programs, ICON CLINICAL RESEARCH
Rhonda Henry, Executive Director, PPD, INC
Michael Massaro, Global Operations Head, Quintiles

In this session, Millennium came together with their CROs to discuss how to optimize their relationships and create the most productive work environment for all involved.  Here are a few of the key ideas to come out of the session:

Rhonda Henry, PPD: Managing the budget is a very challenging part of research. Ops minded individuals are not trained to think financially, but they must be worked with so that they understand. It’s important to talk with the team constantly to communicate changes and accommodations to work with that.

Michael Massaro, Quintiles: Through continuing dialogue with the CRO, constant communication is important. Continuing dialogue is a great strategy to overcome the resistance to change.

Kimberly Glen, ICON Clinical Research: Set up expectations for the partnership at the beginning of conversations for projects. Lay the fundamental groundwork. Agree to the success factors upfront. At Icon, taking the information gained at the beginning, so that those in the field can be train, including  project managers.

Q: Need and ability to impact and be the voice for Millennium (Sponsor)?

Henry: She’s an agent of change for the relationship between the two companies. She’s the voice of PPD to Millennium and shares the expectations on both sides. They employees need to have a clear view of what they’re doing for Millennium.

Glen: Ensuring that things get done internally and work cross divisionally, working with these people to execute and ultimate success for the studies.

What is the best way to manage the success of the team?
- Train, train & Train, it’s unique at Millennium. New skills needed.
- What to measure. People love metrics, but often it’s jumbled. Find key indicators.
- Celebrate success. It’s much more motivating to do it this way.





Join us at Partnerships in Clinical Trials Asia this September in China!

September 12-14, 2012
Shanghai, China

Did you enjoy the Tackle the Challenges of Conducting Clinical Trials in China Summit at Partnerships 2012 or with you were able to attend?  We invite you to go further in depth on this topic and explore Partnerships in Clinical Trials Asia!  It is the premier event for global and regional clinical leaders to build effective partnerships and implement innovative strategies to ensure clinical development success in Asia.

Conducting clinical research in Asia is no longer simply a strategy to improve timelines and cost savings – it is the only way to maintain a globally competitive pipeline. At Partnerships Asia, there is:
  • - More Clinical Development and Trial Operation Experts than any other event.
  • - More Countries represented than any other event.
  • - More new industry case studies than any other event.
  • - More face time with clinical service providers than any other event.
  • - Proven strategies to partner more effectively with Local CROs and Global Multinational CROs
  • - New techniques to develop new Partnerships between Pharma, academia, biotech, and government
For more information on this event and to sign up for updates, visit our homepage!




Monday, March 5, 2012

#PCTUS 2012: Optimal Outsourcing Strategies & How to RockCF

Prevent Supply Chain Disruptions to Ensure Optimal Quality and Improve Clinical Operations
Janelle Sabo, PharmD, RPh, CA-AM, Sr. Director, Global Clinical Trials Materials Services, ELI LILLY

The seven step to getting the supply chain right: Supply planning, label generation, order generation, packaging, distribution, management of inventory, returns, destructions, reconciliation.

The goals of clinical trial material distribution should be high levels of customer service, high levels of distribution efficiency and appropriate investment in inventory stock.

Where are the opportunities? Many sites don’t have adequate refrigerators space. It’s important that Pharma understands how much of their supplies can go where without being wasted due to this problem. In emerging markets, regulations change quickly. The ability to understand the changing regulations is important and can actually help ability to import/export clinical trial materials. China, Ukrane, Brazil, Chile, Korea are all very expensive when it comes to importing materials. Sobo looks at where the work on the clinical trial is going to be done as opposed to where the clinical trial is taking place to save time and Monday.

Michael McNear, RPh, Global Head, Clinical Supply Chain Optimization, FISHER CLINICAL SERVICES
There’s a need to do a robust initial plan. People who have supply chain backgrounds, applying them to clinical trials are increasing the benefits. What’s the randomization scheme? They have to be put into the supply plan. What happens after we start our trial? Planning ahead creates a smoother transition when trial plans change.

How to Conduct Clinical Trials in China when You are Not Big Pharma
Stephen Porter, CEO, VDDI PHARMACEUTICALS

Why is Porter’s operations embracing China? Just as with the themes of the morning session, he also reiterates that China is a huge market and it’s growing. You have to do clinical trials to be on the market in China. There are 2.2 billion hospital visits every year. The multinations have spent $3 billion over the past few years. Embrace and work to the different ethnicities in China – some drugs have been more significant in different populations in Asia. A global rollout in China must account for the significant differences in their language. SFDA reviewers are held accountable for 10 years, this explains why there is often a significant amount of time with response with regards to drugs. China needs to be embraced earlier in the clinical trials process, and then the loss to the global sales program is only a year.

Strategy? Three large problems: hospital infrastructure, physicians and underreporting of AEs. Corruption throughout the country often affects academia, industry and 3rd party (stakeholders, patients and support organizations)

Protect your Intellectual Property: Tools for Patent Protection when Conducting Trials in China
Weihong Hsing, Patent Attorney, PANITCH SCHWARZE BELISARIO & NADEL LLP

China is a member of the World Intellectual Property Organization. It still stays on the priority watch list. China has a first to register system, and there can be no evidence of prior ownership. This can result in a broad trademark protection. China as a country is shifting from the copying mode to the inventing role, which is why patent protection is increasing in focus. You cannot get a method of diagnosis or treatment. In China, if you publicize your invention anywhere, it may no longer have novelty and therefore affecting your patent. The US will adopt this in 2013. In the US, you don’t have to disclose your genetic resources, but in the US you do. Ownership and compensation should be done in an agreement. If possible, you should avoid joint ownership.

Special IP panels in China’s civil court system handle IP cases. There is a strong burden on the platnif to prove their case in China. It’s important to document everything in writing. China has a split patent litigation system. The court determines infringement, and the Patent Office (PRB) hears the patent invalidity challenge. You want to avoid litigation. Foreign companies are increasingly sued for IP infringement. If you are doing clinical trials in China, you want to make sure you’re not infringing upon anyone’s IP patents.

Beating the Odds—Not Only Living with Cystic Fibrosis—Rocking It

Emily Schaller, Founder, ROCK CF FOUNDATION, CF Patient, Clinical Trial Participant, Marathon Runner
Q&A: Peter Mueller, PhD, CSO & Executive Vice President, Global Research & Development, VERTEX PHARMACEUTICALS

On her 21st birthday, her brother and her threw a rock benefit to raise money for cystic fibrosis. From that point on, she began finding ways to raise money for her nonprofit she started, Rock CF. In 2007, she began to run. She pointed out that after she started running for these causes, she started running and it started helping her lung function.

She began a clinical trial with a little blue pill – calicao. One pill twice a day improves the basic defect of CF.  She hopes that this can lead to more treatments and makes the lives of those with cystic fibrosis better, and hopefully the children born with this today will be able to avoid many of the treatments CF patients today work with.  For more on Emily's foundation, visit The Rock CF Foundation's webpage.




Comprehensive Sample Management Workshop: Offsite, Onsite and Hybrid Outsourcing Models

Date: Tuesday, March 6, 2012
Time: 7:30 am – 9:00 am
Location: Anaheim Room, The Marriott World Center, Orlando, Florida
Register Online: www.biostorage.com/workshop

Biostorage will be at booth #704 at Partnerships in Clinical Trials.

About the Workshop:
Achieve research efficiencies and reduce costs by taking a strategic approach to comprehensive sample management.  Learn from the experts on the value of offsite, onsite and hybrid sample management outsourcing models.

Agenda :
Research samples are invaluable scientific assets that are foundational to drug discovery and development. Three new outsourcing models for the management of sample assets have emerged that include offsite, onsite and hybrid sample management solutions. These models focus on leveraging people, process and technology improvements to support an organization in achieving budget savings, research efficiencies and faster speed to market.

This in-depth workshop will focus on new global sample management solutions and will discuss:
• How to assess your internal and external resources and build a comprehensive approach to managing the lifecycle of sample assets and mitigate risk
• Which sample management model may be best for your organization to enhance research efficiencies and speed drugs to market faster
• Strategies for reducing the cost of sample management while maintaining quality
• Examples of how to leverage process and technology to virtually manage scientific sample assets and associated data

Moderator:
Lori Ball, Chief Operating Officer, BioStorage Technologies, Inc.
Expert Panel :
Kristina Robson, Scientific Director, Bioscience Division, EMD Millipore
Mary Rose Keller, Vice-President Clinical Operations, Sangart
Steve Sweeney, Head of Clinical Information Systems, Infinity
Jay Schiestle, Senior Director of Operations, Exact Sciences, Inc.




Partnerships in Clinical Trials Latin America coming this August!


August 13-15, 2012
Sao Paulo, Brazil

From the producers of Partnerships in Clinical Trials, taking place week in Orlando, we'd like to share information on Partnerships in Clinical Trials Latin America!  This event is the largest meeting of clinical trial leaders from around the world partnering to accelerate innovation, increase efficiency and Improve Quality and Clinical Research and Operations in Latin America
  • - Over 80% new faculty featuring clinical trial leaders from Mexico, Argentina, Brazil, Peru, Chile, Colombia, EU, US, and Asia Provoke Change and Inspire Action
  • - The only event with an Innovation Summit for Regional Clinical Trial and R&D Leadership
  • - The most interactive and collaborative event in the region
  • - Keynote Presentations from Global Leaders
  • - Regional Case studies to learn from your peers
  • -  Unmatched standards for quality content

For more information and to sign up for updates on this event, visit the webpage.




#PCTUS 2012: China: Growth and Opportunity for Clinical Trials

This year, we have a track specifically dedicated to delivering strategies conducting clinical trials in China. Some trends that have emerged over the morning are that the China is large, and growing. The government is investing more in public health, and clinical trials are one of the areas growing because of this.

Discovering the unknown: Is China really the Next Nirvana?
James Garner, Vice President & General Manager , TAKEDA GLOBAL RESEARCH & DEVELOPMENT CENTER (ASIA)

In 2015, it’s projected that China will be the second largest Pharma market, behind the US. Why is it happening? As colonies transform and integrate, we see an expansion of GDP, the growth of middle class and a desire for western medical care. China is early in this process. Still, a significant amount of the healthcare is still Chinese medicine, yet it’s hard to quantify. There is an enormous generic market; 70-80% of products sold are generic. The proportion of the market available for brand name products is 10-20% of the market. China is attractive to Pharma is because of the large human population, it’s 20% of all people on this planet.

There are 19,712 hospitals that can conduct clinical trials. The bulk of hospitals are in Level 1&2 and are primary care focused. They are limited in scope for clinical trials and mostly inaccessible. Hospitals in China need to be certified by the SFDA before they can participate in clinical trials. There are 356 that qualify. They’re largely concentrated in the eastern part of China. It is very diverse in biological terms. Standards are dramatically different between China and western medicine. China is growing off of a low base and clinical trial participation is modest.

Why has expansion not been greater? The average approval time of clinical trials is 145 days as opposed to 30 days in the US & Japan. China’s market has been designed with generics in mind, making Western experienced companies challenged. The global industry has been moving into China the last eight years. There are a limited number of people in China who have more than 8 years’ experience.

Effectively Partnering to Manage Issues and Tackle Challenges Conducting Trials in China
Wen Chen, Vice President, TIGERMED CONSULTING, LTD.
Candice Zhang, Senior Trial Manager, BOEHRINGER-INGELHEIM INTERNATIONAL TRADING (SHANGHAI) CO., LTD

A major concern for companies conducting clinical trials is the regulatory system. It’s continuing to evolve. The system is becoming more transparent and sponsor friendly. This environment has to be managed. It’s not an ICH country yet, and the Chinese have their own GCP system, and there’s no major discrepancy between it and IHC. The government has realized its differences in its system, and they’re looking at changing the generic versus name brand doses.

There are a number of China-specific issues. The drugs can be tested locally, but the samples need to be analyzed centrally. Partners in the country are critical because they should know how to engage and drive you through the process. The communication among all trial participants is critical. The CTA will carry the knowledge, and critical for any large sponsor to have one. The SFDA is becoming more science driven. The government’s commitment is to make their citizens lives better and encouraging clinical trials to do that. CROs should fully understand the terms in the contract and communicate with the sponsors the difficulties that may arise.

In China, after clinical trials are approved, then it can begin. There are a lot of competing trials, especially in highly academic sites (ex: Beijing, Shanghai). Many sponsors will go to level 3 hospitals, thus limiting the sites. Many sites have to many clinical trials to manage.


Lessons learned from 15 years of Central Lab experience in China
Patrice Hugo, PhD, Senior Global Director, Scientific Affairs, LABCORP CLINICAL TRIALS

Major trends in the industry: China is growing fast and their government is heavily investing in the healthcare system. The shift is moving from generic drugs to brand name drugs. The gap between clinical trial costs inside of China versus outside of China are closing. Very few sites are able to run clinical trials, but more are becoming certified. It is no longer easy to send samples out or bring them into China. In the clinical trial permit, it is important to have your sample schedule set out.

When it comes to exporting samples, the sites are responsible for this. One site can be responsible for all sites on an application. Since China is a large place, it is vital to have reliable domestic logistics must be in place. Choosing the right courier can significantly decrease your risk mitigation. Alternate routes of transportation are important when sponsors are choosing a courier to make sure samples can get where they need to go. Samples need to be cared in China with other outside to make sure they are comparable. To avoid turnover, critical Smart compensation strategies to keep top talent in this country is also important. Industry trends, experiences, import/export, domestic shipments, control your destiny, act local think global and commitment.




Friday, March 2, 2012

2nd Annual Partnerships in Clinical Trials Awards: Clinical Trial Business Women of the Year

Next week at the 21st Annual Partnerships in Clinical Trials, we'll be hosting the 2nd Annual Partnerships in Clinical Trials Awards.  Celebrate the accomplishments of the industry and your peers at the second annual award ceremony!

Today, we're revealing the nominees for Clinical Trial Business Women of the Year. This award recognizes a woman who has exemplified strong & innovative leadership and has set an example to other women in the clinical trials industry on a global scale.

The Nominees are:
  • - Patricia Leuchten, President, The Avoca Group 
  • - Lisa Hornick, MD, Vice President of Global Pharmacovigilance & Medical Communications, Pharmaceutical Product Develoment, LLC (PPD) 
  • - Joy Frestedt, President & CEO, Frestedt, INC
  • - Darlene Panzitta, President, DSP Clinical
  • - Sheila Rocchio, Vice President of Marketing, PHT Corporation
  • - Gena Reed, CEO, Paragon Biomedical
  • - Susan Blaustein, Manager, Procurement, GlaxoSmithKline
  • - Frances Grote, Senior Director, Clinical Outsourcing, Millennium Pharmaceuticals
  • - Patricia Larrabee, RN, NP, CCRC, President & CEO, Rochester Clinical Research


Voting will take place next week in Orlando.  If you'd like to vote for this category, register to join us for the awards, and mention code XP1700BLOG to receive 15% off the standard rate!




2nd Annual Partnerships in Clinical Trials Awards: Product Approval

Next week at the 21st Annual Partnerships in Clinical Trials, we'll be hosting the 2nd Annual Partnerships in Clinical Trials Awards.  Celebrate the accomplishments of the industry and your peers at the second annual award ceremony!

Today, we're revealing the nominees for Product Approval. As of November 2011, the US FDA had approved 35 new medicines- many of them important advances for patients. This award will honor the company that has used a novel partnering approach to receive market approval for their product.

The Nominees are:
  • - Peter Mueller, CSO and EVP Global R&D, Vertex Pharmaceuticals
  • - Jon Lee, Vice President, Development Operations, Cerexa
  • - Ann Wang, VP, Clinical Operations & Data Management, Human Genome Sciences, Inc.

Voting will take place next week in Orlando.  If you'd like to vote for this category, register to join us for the awards, and mention code XP1700BLOG to receive 15% off the standard rate!




Thursday, March 1, 2012

2nd Annual Partnerships in Clinical Trials Awards: Novel Application of Technology for Clinical Trials

Next week at the 21st Annual Partnerships in Clinical Trials, we'll be hosting the 2nd Annual Partnerships in Clinical Trials Awards.  Celebrate the accomplishments of the industry and your peers at the second annual award ceremony!

Today, we're revealing the nominees for Novel Application of Technology for Clinical Trials. Technology has the power to improve the way the world works and lives. This award recognizes a person and/or company for their innovative vision and use of technology to improve clinical trials.

The Nominees are:
  • - Jae Chung, Founder & CEO, goBalto
  • - Keith Howells, SVP Product Development, OmniComm Systems, Inc.
  • - Jo Kim, Director of Clinical Operations, Shire Pharmaceuticals 
  • Elisabeth Overend, Associate Director, Global Marketing, Phase II-IV, Clinical Development, Covance, Inc
  • Jim Dorsey, Vice President, Bioclinica, Inc.
  • Stacy Weil, MS, RDH, Executive Director, Performance Optimization, Pharmaceutical Product Development, LLC (PPD)
Voting will take place next week in Orlando.  If you'd like to vote for this category, register to join us for the awards, and mention code XP1700BLOG to receive 15% off the standard rate!